Multifocal HD-tDCS and Motor Function

Официальное название

Personalizing Multifocal Transcranial Direct Stimulation Dose to Target the Motor Network in Older Adults

Обзор

The purpose of this study is to understand how the brain controls movement and how Non-invasive Brain Stimulation (NIBS) with a technique called High-density transcranial direct current stimulation (HD-tDCS) can alter brain processes to improve behavior. Participants in this study will be randomized to either HD-tDCS with standard intervention or personalized dose-controlled multifocal network-targeted HD-tDCS. The hypothesis is that dexterous hand function will improve after a standard HD-tDCS dose and increase even more after personalized dose-controlled multifocal network-targeted HD-tDCS.

Подробное описание

This project is the first of two projects. The second project will be registered as a separate project in the future and enroll participants from this project.

Вмешательства

• Устройство Standard HD-tDCS intervention
  Participants will have three sessions along with behavioral assessments.
• Устройство Multifocal network targeted HD-tDCS intervention
  Participants will have three sessions along with behavioral assessments.
• Устройство Functional Magnetic Resonance Imaging (fMRI)
  Participants will have an MRI before or after having HD-tDCS intervention.

Первичные конечные точки

• Percent change in precision force-tracking task [Срок оценки: Baseline and 24 hours after the third sessions are completed]
• Percentage change in the time to complete the nine-hole peg test (9-HPT) [Срок оценки: Baseline and 24 hours after the third sessions are completed]

Вторичные конечные точки (1)

• Percentage change in the mean choice reaction time [Срок оценки: Baseline and 24 hours after the third sessions are completed]

Критерии участия

Критерии включения

• Participants should be in good health with normal or corrected-to-normal visual acuity
• Right handed
• No history of neurological disorder
• English speaker
• Able to provide written consent prior to admission

Критерии исключения

• Left-handed
• Participants are pregnant, suspect pregnancy or are attempting to become pregnant
• Have a pacemaker, intracardiac lines or any other medically implanted device or medicine pump
• Have cochlear hearing implants
• Taking drugs known to influence neural receptors that facilitate neuroplasticity (see protocol)
• Have non removable body piercings or have foreign objects in body
• Have metal anywhere in the head that could increase risk of serious injury (not including braces, dental fillings, etc.) (see protocol)
• Have a personal or family history of seizure/epilepsy
• Taking prescription drugs that lower the threshold for seizures
• Recent history of excessive alcohol consumption
• History of alcohol addiction/dependence
• Recent history of recreational drug use
• History of drug addiction/dependence
• Recent history of recreational drug use
• History of drug addiction/dependence
• Diagnosed with a stroke, brain hemorrhage, brain tumor, encephalitis.
• Diagnosed with multiple sclerosis
• Diagnosed with Parkinson's disease or Alzheimer's disease
• Diagnosed with depression in the past 6 months
• Diagnosed with attention deficit disorder, schizophrenia, manic depressive (bipolar) disorder
• Diagnosed with normal pressure hydrocephalus or increased intra-cranial pressure
• Diabetes requiring insulin treatment
• Any serious heart disorder or liver disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT06561165 · HUM00250171 · 5P2CHD086844-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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